A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy

Annals of Oncology

Volumn 17, Issue 9, 2006, Pages 1441-1449

  Aapro, M S ^a   Grunberg, S M ^b   Manikhas, G M ^c   Olivares, G ^d   Suarez, T ^e   Tjulandin, S A ^f   Bertoli, L F ^g   Yunus, F ^h   Morrica, B ⁱ   Lordick, F ^j   Macciocchi, A ^k  

^a CLINIQUE DE GENOLIER   (Switzerland)

^b UNIVERSITY OF VERMONT   (United States)

^c St Petersburg Oncology Center   (Russian Federation)

^d INSTITUTO MEXICANO DEL SEGURO SOCIAL   (Mexico)

^e Centro Anticanceroso   (Mexico)

^f Russian Oncology Center   (Russian Federation)

^g Southern Hematology and Oncology   (United States)

^h Boston Baskin Cancer Group   (United States)

ⁱ CREMONA HOSPITAL   (Italy)

^j TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^k Helsinn Healthcare ^*  (Switzerland)

more..

Author keywords

Chemotherapy induced nausea and vomiting; Emesis; Highly emetogenic chemotherapy; Palonosetron

Indexed keywords

ANTINEOPLASTIC AGENT; CARMUSTINE; CHLORMETHINE; CISPLATIN; CYCLOPHOSPHAMIDE; DACARBAZINE; DEXAMETHASONE; ONDANSETRON; PALONOSETRON;

ADULT; ARTICLE; BREAST CANCER; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; ECG ABNORMALITY; FEMALE; HEADACHE; HODGKIN DISEASE; HUMAN; LUNG CANCER; MALE; NAUSEA AND VOMITING; OVARY CANCER; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; STOMACH CANCER;

EID: 33748749890     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdl137     Document Type: Article

References (49)

1. Hesketh PJ. Defining the emetogenicity of cancer chemotherapy regimens: relevance to clinical practice. Oncologist 1999; 4: 191-196.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology-Antiemesis - v.1.2005. Available at: http://www.nccn.org/professionals/physician_gls/PDF/antiemesis.pdf. Date last accessed: March 1, 2005.
3. Multinational Association of Supportive Care in Cancer (MASCC). 2004 Perugia Antiemetic Consensus Guidelines. Support Care Cancer 2005; 13: 77-131,
4. 3 receptor antagonists for the prevention of chemotherapy-induced nausea and vomiting: A comparison of their pharmacology and clinical efficacy. Drugs 1998; 55: 173-189.
5. Kris MG, Hesketh PJ, Herrstedt J et al. Consensus proposals for the prevention of acute and delayed vomiting and nausea following high-emetic-risk chemotherapy. Support Care Cancer 2005; 13: 85-96.
6. Del Favero A, Roila F, Tonato M. Reducing chemotherapy-induced nausea and vomiting: Current perspectives and future possibilities. Drug Saf 1993; 9: 410-428.
7. Grunberg SM, Akerley WL, Krailo MD et al. Comparison of metoclopramide and metoclopramide plus dexamethasone for complete protection from cisplatinum-induced emesis. Cancer Invest 1986; 4: 379-385.
8. Kris MG, Gralla RJ, Clark RA et al. Incidence, course, and severity of delayed nausea and vomiting following administration of high-dose cisplatin. J Clin Oncol 1985; 3: 1379-1404.
9. Roila F, Boschetti E, Tonato M et al. Prediction factors of delayed emesis in cisplatin treated patients and emetic activity and tolerability of metoclopramide or dexamethasone: A randomized single-blind study. Am J Clin Oncol 1991; 14: 238-242.
10. 3 receptor antagonists. Exp Opin Pharmacother 2000; 1: 207-223.
11. Egerer G, Hegenbart U, Salwender HJ et al, Treatment of chemotherapy-induced emesis. Antibiot Chemother 2000; 50: 171-183.
12. 3 receptor antagonists in the treatment of acute chemotherapy-induced nausea and vomiting. Cancer Invest 2000; 18: 163-173.
13. 3 receptor antagonists to conventional anti-emetics in the prophylaxis of acute chemotherapy-induced vomiting. Eur J Cancer 1997; 33: 66-74.
14. Forni C, Ferrari S, Loro L et al. Granisetron, tropisetron, and ondansetron in the prevention of acute emesis induced by a combination of cisplatin-Adriamycin and by high-dose ifosfamide delivered in multi-day continuous infusions. Support Care Cancer 2000; 8: 131-133.
15. Gralla RJ, Osoba D, Kris MG et al. Recommendations for the use of antiemetics: Evidence-based, clinical practice guidelines. J Clin Oncol 1999; 17: 2971-2994.
16. 3 antagonists in chemotherapy-induced nausea and vomiting. Clin Oncol 2001; 13: 422-426.
17. Johnston D, Latrielle J, Laberge F et al. Preventing nausea and vomiting during days 2-7 following high-dose cisplatin chemotherapy (HDCP). A study by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). Proc Am Soc Clin Oncol 1995; 14: 529 (abstr).
18. Grunberg SM, Deuson RR, Mavros P et al. Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer 2004; 100: 2261-2268.
19. Hickok JT, Roscoe JA, Morrow GR et al. Nausea and emesis remain significant problems of chemotherapy despite prophylaxis with 5-hydroxytryptamine-3 antiemetics. A University of Rochester James P. Wilmot Cancer Center Community Clinical Oncology Program Study of 360 Cancer Patients Treated in the Community. Cancer 2003; 97: 2880-2886.
20. Kaizer L, Warr D, Hoskins P et al. Effect of schedule and maintenance on the antiemetic efficacy of ondansetron combined with dexamethasone in acute and delayed nausea and emesis in patients receiving moderately emetogenic chemotherapy: A phase III trial by the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 1994; 12: 1050-1057.
21. Osoba D, Zee B, Warr D et al. Effect of postchemotherapy nausea and vomiting on health-related quality of life. Support Care Cancer 1997; 5: 307-313.
22. Ihbe-Heffinger A, Ehlken B, Bernard R et al. The impact of delayed chemotherapy-induced nausea and vomiting on patients, health resource utilization and costs in German cancer centers. Ann Oncol 2004; 15: 526-536.
23. 3 receptors, in vitro. Br J Pharmacol 1995; 114: 851-859.
24. Stoltz R, Cyong JC, Shah A et al. Pharmacokinetic and safety evaluation of palonosetron, a 5-hydroxytryptamine-3 receptor antagonist, in US and Japanese healthy subjects. J Clin Pharmacol 2004; 44: 520-531.
25. Aloxi® (palonosetron HCl) prescribing information. Damastown, Dublin, Republic of Ireland: Helsinn Birex Pharmaceuticals Ltd., 2005; Bloomington, MN, USA: MGI PHARMA, INC., 2006.
26. 3 receptor antagonist: Results of a phase III, single-dose trial vs dolasetron. Cancer 2003; 98: 2473-2482.
27. Gralla R, Lichinitser M, Van der Vegt S et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: Results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol 2003; 14: 1570-1577.
28. Rubenstein EB et al. Palonosetron (PALO) compared with ondansetron (OND) or dolasetron (DOL) for prevention of acute & delayed chemotherapy-induced nausea and vomiting (CINV): Combined results of two phase III trials. Proc Am Soc Clin Oncol 2003; 22: 729 (Abstr 2932).
29. Eisenberg P, MacKintosh FR, Ritch P et al. Efficacy, safety and pharmacokinetics of palonosetron in patients receiving highly emetogenic cisplatin-based chemotherapy: A dose-ranging clinical study. Ann Oncol 2004; 15: 330-337.
30. Lindley CM, Hirsch JD, O'Neill CV et al. Quality of life consequences of chemotherapy-induced emesis. Qual Life Res 1992; 1: 331-340.
31. Martin AR, Pearson JD, Cai B et al. Assessing the impact of chemotherapy-induced nausea and vomiting on patients' daily lives: A modified version of the Functional Living Index-Emesis (FLIE) with 5-day recall. Support Care Cancer 2003; 11: 522-527.
32. Massaro AM, Lenz KL. Aprepitant: A novel antiemetic for chemotherapy-induced nausea and vomiting. Ann Pharmacother 2005; 39: 77-85.
33. Minami M, Endo T, Hirafuji M et al. Pharmacological aspects of anticancer drug-induced emesis with emphasis on serotonin release and vagal nerve activity. Pharmacol Ther 2003; 99: 149-165.
34. Grunberg SM, Hesketh PJ. Control of chemotherapy-induced emesis. N Engl J Med 1993; 329: 1790-1796.
35. Cubeddu LX, Hoffman IS, Fuenmayor NT et al. Efficacy of ondansetron (GR 38032F) and the role of serotonin in cisplatin-induced nausea and vomiting. N Engl J Med 1990; 322: 810-816.
36. Borison HL, McCarthy: Neuropharmacology of chemotherapy-induced emesis. Drugs 1983; 25: 8-17.
37. Gardner CJ, Bountra C, Bunce KT et al. Anti-emetic activity of neurokinin NK1 receptor antagonists is mediated centrally in the ferret. Br J Pharmacol 1994; 11: 516P.
38. Otsuka M, Yoshioka K. Neurotransmitter functions of mammalian tachykinins. Physiol Rev 1993; 73: 229-308.
39. Minegishi Y, Ohmatsu H, Miyamoto T et al. Efficacy of droperidol in the prevention of cisplatin-induced delayed emesis: A double-blind, randomized parallel study. Eur J Cancer 2004; 20: 1188-1192.
40. Hesketh PJ, Van Belle S, Aapro M et al. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer 2003; 39: 1074-1080.
41. Flake ZA, Scalley RD, Bailey AG. Practical selection of antiemetics. Am Fam Physician 2004; 69: 1169-1174.
42. Fromer MJ. Chemotherapy-induced nausea & vomiting: Research update on improving control. Oncology Times 2005; 27: 29-30, 33.
43. Vardy J, Chiew KS, Galica J et al. Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br J Cancer 2006; 94: 1011-1015.
44. Gralla RJ, Navari RM, Hesketh PJ et al. Single-dose granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy. J Clin Oncol 1998; 16: 1568-1573.
45. Perez EA, Hesketh P, Sandbach J et al. Comparison of single-dose granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy: A multi-center double-blind randomized parallel study. J Clin Oncol 1998; 16: 754-760.
46. The Italian Group for Antiemetic Research. Dexamethasone, granisetron, or both for the prevention of nausea and vomiting during chemotherapy for cancer. N Engl J Med 1995; 332: 1-5.
47. Hesketh PJ, Harvey WH, Harker WG et al. A randomized, double-blind comparison of intravenous ondansetron alone and in combination with dexamethasone in the prevention of high-dose cisplatin-induced emesis. J Clin Oncol 1994; 12: 596-600.
48. Emend® (aprepitant) prescribing information. Whitehouse Station, NJ, USA: Merck & Co., Inc., 2004.
49. Grote T, Hajdenberg A, Cartmell S et al. Palonosetron plus aprepitant and dexamethasone is a highly effective combination to prevent chemotherapy-induced nausea and vomiting after emetogenic chemotherapy. Eur J Cancer 2005; 3: 371 (abstr).